Atrial FibrillationTriggersAFNCT05526170
Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring
An observational study of Atrial Fibrillation and Atrial Flutter, run by Vilnius University at 1 site in Lithuania.
Trial summary
A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- What is being tested?
- Devices for long-term monitoring of objective and subjective parameters of the body
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Aug 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
Who may be able to join
- Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
- An informed consent is signed by the patient.
Who cannot join
- The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
- Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
- Patients with permanent atrial fibrillation or permanent atrial flutter.
- Age <18 years.
- Patients with a pacemaker or an implanted cardiovert-defibrillator.
- Patients suffering from dementia or other severe neurological disorders and thus incapable to participate.
- Patients who present with antisocial behavior and/or do not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Detection of Triggers and Risk Factors for Recurrence of Atrial Fibrillation and Other Atrial Arrhythmias With the Use of Long-term Monitoring
A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia, Atrial Tachycardia, Premature Atrial Contractions, Arterial Hypertension
- Being tested
- Devices for long-term monitoring of objective and subjective parameters of the body
- Keywords
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmias, Arterial Hypertension, Triggers, Sleep disorders, Sleep apnea, Telemedicine, Mhealth, Remote monitoring, Digital health
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Atrial Premature Complexes, Hypertension, Sleep Wake Disorders, Sleep Apnea Syndromes, Sedentary Behavior, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Devices for long-term monitoring of objective and subjective parameters of the bodyDevice
Patients will use a 1-lead Holter ECG (Bittium Faros) for heart rhythm and physical activity analysis, a wearable wrist-worn device with photoplethysmography and 6-lead ECG for heart rhythm analysis, a sleep tracking mat (Withings sleep analyser) for sleep analysis, a smartphone with triggers application for entering the subjective triggers (stress, coffee, alcohol intake and others), a 48-hour ambulatory blood pressure monitor for 2 days and a regular blood pressure monitor for up to 5 days. Patients will be monitored for up to 7 days with the described system of devices. In addition, patients will receive investigations of heart echocardiography, laboratory tests and surveys to evaluate the system and the use of acquired information.
| Study group | Role | What they receive |
|---|---|---|
| Patients with previously diagnosed paroxysmal or persistent atrial fibrillation | Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time. During trial period subjects will be monitored for different atrial arrhythmias and divided into the following subgroups: atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions (bigeminy, trigeminy, couplets), multiple atrial arrhythmias and no arrhythmia detected. Receives: Device: Devices for long-term monitoring of objective and subjective parameters of the body |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Patterns of blood pressure fluctuations in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. An association between episodes of uncontrolled arterial hypertension and occurrence of arrhythmia episodes is anticipated.
Measured: 7 days
Secondary outcomes (10)
Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Patterns of distinct triggers in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. Mobile application and accelerometer of Holter ECG device will be used to record these factors as well as mark the time and the frequency of these actions. Attempts will be made to link all patient-marked triggers, their frequency, time of onset to the occurrence of arrhythmia.
Triggers such as:
coffee intake alcohol consumption distinguished by strength into:
- spirits: brandy, vodka,
- vine or champagne
- low alcohol drinks: beer, cider emotional stress, overeating, physical activity, strenuous exercise, cold food, cold drink, lack of sleep other activities or things participants feel are related to the onset of arrhythmias
Measured: 7 days
Association of available blood tests results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Blood tests may be useful in determining the effect of concomitant illness, their exacerbations, or, conversely, the stable course of the disease on the arrhythmia.
Available results of each separate test (potassium, sodium, magnesium, BNP, creatinine, glomerular filtration rate, lipid profile, c-reactive protein) in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a period of 3 months prior to 3 months after inclusion.
Measured: 3 months prior to 3 months after inclusion
Association of sleep analysis data with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Each participant will be given a sleeping mat to put under the mattress and data collected from it in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.
Measured separately as:
Sleep Quality Index, Apnea Episodes, Snoring Episodes, Snoring (%), Sleep Duration (Hours), Regular Sleep, Sleep Depth, Sleep Breaks
Measured: 7 days
Temporal relation between changes in blood pressure and atrial arrhythmias in patients with previously diagnosed atrial fibrillation
The results from the 48-hour blood pressure measurements (ambulatory BPM Mobil-o-graph's data) and additional 5 days measurements (Withings BPM) will be used to describe temporal relation between changes in blood pressure and atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. The temporal relation will be measured as a time of blood pressure rise/fall before arrhythmia occurrence personalized for each individual and generalized for groups of individuals.
Collected data:
date, time, systole mean arterial pressure, Diastole, Peripheral pulse pressure (pPP), Heart rate (Hr), cSPB, cDBP, MAP-C2 (calibration for calculating the aortic central systolic blood pressure)
Measured: 7 days
Association of echocardiographic results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Echocardiography parameters will show cardiac status and function: chambers sizes, presence of left ventricular (LV) hypertrophy, atrial enlargement; the strains of left atrium and the predicted risk of these parameters in relation to atrial arrhythmias. Echocardiography will be acquired within a period of 3 months prior to 3 months after inclusion.
Echocardiography parameters: Main: LV ejection fraction (LV EF) (%), LV end diastolic diameter (LVdd) (cm), Interventricular septal diameter (IVd) (cm), LV posterior wall diameter (LVPWd) (cm), E and A waves (m/s), Left atrial diameter (cm), LA volume index (ml/m2), LA maximum volume (ml), E' lat, E' med (cm/s), E' vid, E/e' vid, E deceleration time (ms). Additional parameters (%): mean contractile strain, 4 chamber (4 CH) contractile strain, 2 CH contractile strain, mean conduit strain, 4 CH conduit strain, 2 CH conduit strain, mean reservoir strain (%), 4 CH reservoir strain (%), 2 CH reservoir strain (%).
Measured: 3 months prior to 3 months after inclusion.
Association of parasympathetic and sympathetic tone to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
The activity of autonomic nervous system will be measured as heart rate variability (HRV), standard deviation of normal-to-normal heart rate intervals (SDNN) and other parameters in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.
Measured: 7 days
Association of physical activity to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
To assess level of physical activity (measured as MET and the number of steps taken per day) in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days.
Measured: 7 days
Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation before monitoring
Before the start of monitoring participants will fill out the questionnaire of most frequent known triggers, which could provoke their arrhythmias as well as mark the arrhythmia-related symptoms and the burden of arrhythmia in everyday life.
Measured: 1 day
Usability of devices in everyday use
After the monitoring of 7 days participants will fill out the questionnaire of the convenience of each device and the willingness to use them if recommended by a physician in everyday practice.
Measured: 1 day
Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation after the collected information is presented to the patients
At least 3 months after the collected monitoring results are presented to the patients, the participants will fill out the questionnaire about changes of perceived potential triggers, symptoms, burden of arrhythmia and the quality of life ad symptoms.
Measured: 3 months after the collected information is presented to the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Aug 2021
- Primary completion15 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaunas University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526170
- Sponsor's protocol ID
- TriggersAF
- Acronym
- TriggersAF
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Detection of Triggers and Risk Factors for Recurrence of Atrial Fibrillation and Other Atrial Arrhythmias With the Use of Long-term Monitoring
- ClinicalTrials.gov ID
- NCT05526170
- Acronym / sponsor ID
- TriggersAF / TriggersAF
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia, Atrial Tachycardia, Premature Atrial Contractions, Arterial Hypertension
- Keywords
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmias, Arterial Hypertension, Triggers, Sleep disorders, Sleep apnea, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Kaunas University of Technology
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with previously diagnosed paroxysmal or persistent atrial fibrillation | – | Device: Devices for long-term monitoring of objective and subjective parameters of the bodyPatients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time. During trial period subjects will be monitored for different atrial arrhythmias and divided into the following subgroups: atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions (bigeminy, trigeminy, couplets), multiple atrial arrhythmias and no arrhythmia detected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
Key inclusion criteria (2 listed)
- Patients with previously diagnosed paroxysmal or persistent atrial fibrillation who are in sinus rhythm at inclusion time.
- An informed consent is signed by the patient.
Key exclusion criteria (7 listed)
- The qualifying episode of AF has never been documented in ECG or Holter ECG monitoring.
- Patients with atrial fibrillation, atrial flutter or atrial tachycardia at inclusion time.
- Patients with permanent atrial fibrillation or permanent atrial flutter.
- Age <18 years.
- Patients with a pacemaker or an implanted cardiovert-defibrillator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Devices for long-term monitoring of objective and subjective parameters of the bodyPatients will use a 1-lead Holter ECG (Bittium Faros) for heart rhythm and physical activity analysis, a wearable wrist-worn device with photoplethysmography and 6-lead ECG for heart rhythm analysis, a sleep tracking mat (Withings sleep analyser) for sleep analysis, a smartphone with triggers application for entering the subjective triggers (stress, coffee, alcohol intake and others), a 48-hour ambulatory blood pressure monitor for 2 days and a regular blood pressure monitor for up to 5 days. Patients will be monitored for up to 7 days with the described system of devices. In addition, patients will receive investigations of heart echocardiography, laboratory tests and surveys to evaluate the system and the use of acquired information. | Device | Patients with previously diagnosed paroxysmal or persistent atrial fibrillation |
Primary outcome
Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Patterns of blood pressure fluctuations in relation to atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, premature atrial contractions) within a monitoring period of 7 days. An association between episodes of uncontrolled arterial hypertension and occurrence of arrhythmia episodes is anticipated.
10 secondary outcomes
Association of various triggers with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Association of available blood tests results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 3 months prior to 3 months after inclusion
Association of sleep analysis data with atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Temporal relation between changes in blood pressure and atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Association of echocardiographic results to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 3 months prior to 3 months after inclusion.
Association of parasympathetic and sympathetic tone to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Association of physical activity to predict the risk of atrial arrhythmias in patients with previously diagnosed atrial fibrillation
Time frame: 7 days
Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation before monitoring
Time frame: 1 day
Usability of devices in everyday use
Time frame: 1 day
Potential triggers named by participants, symptoms, burden of arrhythmia and the quality of life in patients with previously diagnosed atrial fibrillation after the collected information is presented to the patients
Time frame: 3 months after the collected information is presented to the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure association with atrial arrhythmias in patients with previously diagnosed atrial fibrillation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.